Abbott Vascular's Absorb Bioresorbable Vascular Scaffold Approved in Japan
November 7, 2016—Abbott Vascular announced Japan’s Ministry of Health, Labor, and Welfare has approved the company’s Absorb bioresorbable coronary stent. Sold commercially as the Absorb GT1 bioresorbable vascular scaffold system, the device was recently approved in the United States and Canada, and has been used in more than 100 countries.
Japanese approval of the device was supported by results of the ABSORB JAPAN clinical trial. Prof. Takeshi Kimura, MD, Director of Cardiovascular Medicine at Kyoto University Hospital in Kyoto, Japan, is principal investigator of ABSORB JAPAN. In the company’s press release, Dr. Kimura commented, “Absorb has the potential to address the unsolved challenges of managing coronary artery disease with conventional drug-eluting metallic stents. Our research, which involved 400 patients at 38 Japanese sites, shows that this fully dissolving stent delivered comparable results to the best-in-class Abbott Xience metallic drug-eluting stent on clinically important measures of safety and efficacy.”